ARx G209200_B

by Life Spine, Inc.

Active United States. Also listed in GUDID (US).

510(k)

Valid until

No expiry

510(k) clearance is not time-limited

FDA recalls

in data synced 23 Oct 2026

Documents

FDA submission, from GUDID

Trust

Unverified

Registry data, not yet checked by deviCERTS. Source GUDID, synced 23 Oct 2026. What this means

Regulatory status

as of registry sync 23 Oct 2026

Region	Authorization	Number	Date	Status
United States	GUDID listing	Number00190837205034 UDI-DI	Date8 Jan 2025Listed	StatusListed GUDID: in commercial distribution
United States	FDA 510(k)SESE from GUDID Substantially Equivalent · Traditional	NumberK200070	Date23 Apr 2020Decided	StatusActive

Official records

AccessGUDID record UDI-DI 00190837205034
FDA 510(k) database 510(k) number K200070

Recalls

0 recalls · FDA

No FDA recalls found in the data synced 23 Oct 2026.

Coverage

1 jurisdiction

Active
Expiring
Withdrawn
Listed
Not covered

United States — FDA 510(k) Active

Specification

GUDID

Trade name: ARx
Generic name: Surgical implant/trial-implant/sizer holder, reusable
Model / reference: G209200_B

Primary DI / UDI-DI: 00190837205034
510(k) Number: K200070
FDA product code: NKB
GMDN term: Surgical implant/trial-implant/sizer holder, reusable

Device class: Class II
Regulation number: 888.3070
GUDID distribution status: In Commercial Distribution

Sterilisation method: Moist Heat or Steam Sterilization

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Arx 13-5540-13

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Arx 13-6545-13

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See all devices from Life Spine, Inc. →

Properties

Sterilise before use
Single use
Prescription use
Lot / batch number

Other properties (11)

Supplied sterile: No
Implantable: No
Contains latex: No
Over-the-counter: No
Convenience kit: No
Combination product: No
HCT/P: No
Premarket exempt: No
Serial number: No
Expiration date: No
Manufacturing date: No